Enrolling by invitation NCT03683186

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Phase III Interventional PAH Pulmonary Hypertension Pulmonary Arterial Hypertension Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Ralinepag.
Who it may be relevant to: Registry conditions: PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +28
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

Overview

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Detailed description

Study ROR-PH-303 is a multicenter, open-label extension (OLE) study for subjects with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag and who qualify for entry based upon participation in the prior study. Subjects who discontinue participation in a prior study due to safety issues related to study medication or who fail to complete study procedures will not be eligible to enter Study ROR-PH-303. Subjects who meet all OLE entry criteria will be enrolled and will receive ralinepag in addition to their pre-existing PAH disease-specific background therapy.

For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag study, a 16-week blinded Dose Titration Period will be completed following enrollment into the OLE. Subjects previously on ralinepag will continue on the same dose during the Dose Titration Period as received in the original study and will also initiate placebo treatment in the OLE.

Subjects who are enrolled from a non-blinded study or another OLE will not participate in the blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the Treatment Period and continue on the dose of ralinepag received in the original study.

All subjects will receive ralinepag in the OLE study until premature discontinuation of ralinepag due to an AE/serious adverse event (SAE) or other reason, marketing approval of ralinepag is granted in the region in which the study is conducted, or the study is discontinued by the Sponsor.

Interventions

Drug Ralinepag
Active

Primary outcome measures

Number of subjects with treatment-emergent adverse events [Safety and Tolerability] [Time frame: Up to 6 years]

Eligibility criteria

Inclusion criteria

Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.

Exclusion criteria

Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study.
Subjects who withdrew consent during participation in another ralinepag study.
Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding.
Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study.
Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 48 centers

St. Joseph's Hospital and Medical Center-Norton Thoracic Institute — Phoenix
University of Arizona — Tucson
UCSD Health Sciences — La Jolla
Ronald Reagan UCLA Medical Center — Los Angeles
Keck Hospital of USC — Los Angeles
VA Greater Los Angeles Healthcare System — Los Angeles
University of California, Irvine — Orange
University of California Davis Medical Center — Sacramento
… and 40 more centers

Argentina · 12 centers

Hospital Italiano — Ciudad Autonoma de Buenos Aires
Hospital PROVINCIAL "Dr. Jose Maria Cullen" — Santa Fe
Sanatorio Parque — Rosario
Sanatorio de la Trinidad Mitre — Buenos Aires
Cardiologia Palmero — Caba
Hospital Britanico de Buenos Aires — Ciudad Autonoma Buenos Aires
Fundacion Respirar — Ciudad Autonoma Buenos Aires
Fundacion Favaloro — Ciudad Autonoma Buenos Aires
… and 4 more centers

Australia · 11 centers

Royal Prince Alfred Hospital — Camperdown
St Vincent's Hospital Sydney — Darlinghurst
Macquarie University — Sydney
Westmead Hospital — Sydney
Nepean Hospital — Sydney
The Prince Charles Hospital — Chermside
Princess Alexandra Hospital — Woolloongabba
Royal Hobart Hospital — Hobart
… and 3 more centers

France · 11 centers